Cooper Surgical Incontinence Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 31 units of Incontinence Dish Folding Pessaries because the outer packaging may not reflect the actual product size.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a packaging labeling error rather than a direct safety hazard.
Plain-English summary
Cooper Surgical, Inc. is recalling 31 units of the Incontinence Dish Folding Pessary #0, 55mm (Milex Part Number: MXPCOND00). The recall was initiated because the outer packaging for these devices may be mislabeled and does not accurately reflect the size of the pessary contained within.
A pessary is a medical device inserted into the vagina to provide structural support for the uterus, bladder, and rectum. The affected units are from Lot Number 114287. The distribution of these products was worldwide, including the United States (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
Consumers who possess this specific product should stop using it and contact Cooper Surgical, Inc. for instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
- Manufacturer
- Cooper Surgical, Inc.
- Hazard
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number:114287
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Cooper Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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